Neisseria Meningitidis Gr. Y
FDA 510(k) K840507 · Scientific Device Laboratory, Inc.
510(k) numberK840507
Submission
- Device name
- Neisseria Meningitidis Gr. Y
- Applicant
- Scientific Device Laboratory, Inc.
Mchenry, IL, US - Received
- February 6, 1984
- Decision date
- March 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LSC – Neisseria Controls
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LSC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K840506 | Haemophilus Influenzae Type BLSC · Traditional | Scientific Device Laboratory, Inc. | 04/04/1984SE |
| K840514 | Neisseria Meningitidis ControlLSC · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840510 | Neisseria Meningitidis Gr. aLSC · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840509 | Neisseria Meningitidis Gr. BLSC · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840505 | SDL Neisseria Menningitidis Gr. XLSC · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
| K840504 | SDL Neisseria Meningitides Gr. 2LSC · Traditional | Scientific Device Laboratory, Inc. | 03/23/1984SE |
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| K911059 | Turbidometric StandardLIE · Traditional | 06/10/1991SE |
| K895848 | Pressure Steam SterilizersFLE · Traditional | 12/11/1989SE |
| K890718 | Gram Stain Control SlideLJG · Traditional | 03/16/1989SE |
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| K884069 | Snap N' Stain Iodine StainJTS · Traditional | 10/25/1988SE |
| K884011 | Snap N' Stain Iron StainGGH · Traditional | 10/06/1988SE |
| K883052 | Metheno-Stain KitJTS · Traditional | 08/30/1988SE |
| K881598 | SDL Trichrome StainJTS · Traditional | 05/04/1988SE |
Questions and answers
When was Neisseria Meningitidis Gr. Y cleared by the FDA?
Neisseria Meningitidis Gr. Y (K840507) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 46 days after the submission was received.
What is the product code of K840507?
The FDA product code is LSC – Neisseria Controls, a Class I (low risk) device regulated under 21 CFR 866.2660.